NCT05746143招募中4 期
The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion: A Randomized Control Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Visual analog scale (VAS)
研究概览
简要总结
The purpose of this study is to evaluate if peri-operative zolpidem for posterior lumbar spinal fusion improves patient reported outcomes following surgery.
详细描述
Patients who are undergoing one- to three-level spinal fusion for degenerative lumbar disease will be recruited. They will be randomized to either receive zolpidem or placebo two days preoperatively and five days postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •degenerative lumbar disease
- •age of 18-75
- •undergoing open primary one- to three-level lumbar fusion
排除标准
- •currently use a sleep aid nightly
- •diagnosed with insomnia or sleep apnea
- •history of delirium with opiates or zolpidem
- •allergic to opiates or zolpidem
- •had previous lumbar spine surgery
- •undergoing minimally invasive lumbar fusion,
- •undergoing lumbar fusion for fracture, infection, tumor, or an inflammatory spondyloarthropathy
研究组 & 干预措施
Zolpidem
Experimental
干预措施: Zolpidem Tartrate 10 mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Visual analog scale (VAS)
时间窗: Postoperative day five
Visual analog scale (VAS) for back and leg pain; scale range: 0-10, higher scores = increased pain (worse outcome)
次要结局
- Oswestry Disability Index (ODI)(Preoperative, Postoperative day three, five, as well as two weeks and six weeks)
- Morphine Equivalents(Postoperative day one, two, three, four, five, and two weeks)
- Quality of Recovery - 40 (QoR-40) questionnaire(Preoperative, Postoperative day three, five, as well as two weeks and six weeks)
- Epworth Sleepiness Score (ESS)(Preoperative, Postoperative day three, five, as well as two weeks and six weeks)
- Pain Catastrophizing Scale (PCS)(Preoperative, Postoperative day three, five, as well as two weeks and six weeks)
- Hospital Length of Stay(Postoperative two-weeks)
- Postoperative complications(Postoperative two-years)
- Visual analog scale (VAS)(preoperative, postoperative day one, three, as well as two weeks and six weeks)
研究者
Raymond Hah
Assistant Professor of Clinical Orthopaedic Surgery
University of Southern California
研究点 (1)
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